{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69471",
      "recalling_firm": "Instrumed International, Inc.",
      "address_1": "626 Cooper Ct",
      "address_2": "N/A",
      "postal_code": "60173-4537",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.",
      "recall_number": "Z-0540-2015",
      "product_description": "Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical,  Boss Instruments, Symmetry Surgical, and CareFusion brand names.",
      "product_quantity": "8 Hudson braces",
      "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",
      "recall_initiation_date": "20140908",
      "center_classification_date": "20141208",
      "termination_date": "20171129",
      "report_date": "20141217",
      "code_info": "1) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212.     2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments Item Number: 74-0121; Lot Number: 110212.     3) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical Item Number: 57-6004; Lot Number: 060414.     4) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical Item Number: P-22881; Lot Number: 100211.     5) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion Item Number: VM85-1233; Lot Number: 100211.     6) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments Item Number: 74-0122; Lot Number: 100211."
    }
  ]
}